Method for producing patient-specific plate

ABSTRACT

A method of making a patient specific surgical orthopedic implant includes obtaining a virtual model of the orthopedic implant that is configured to fit over a particular tissue body, and virtually designing holes of the orthopedic implant.

CROSS-REFERENCE TO RELATED APPLICATIONS

This claims the benefit of U.S. Patent Application Ser. No. 61/699,938filed Sep. 12, 2012, the disclosure of which is hereby incorporated byreference as if set forth in its entirety herein.

TECHNICAL FIELD

The present disclosure generally relates to methods and systems forproducing orthopedic implants, and more particularly, to methods andsystems for manufacturing patient-specific mandible plates.

BACKGROUND

Many surgical procedures involve the fixation of orthopedic implants,such as mandible plates, to a bone or a bone graft. One or morefasteners, such as bone screws, can be used to fix the orthopedicimplant to the bone or bone graft. Some orthopedic implants includeimplant holes that are configured to receive fasteners. As such, theseorthopedic implants can be attached to the bone or bone graft byinserting a fastener through each implant hole and into the bone or bonegraft. However, it is important that the fasteners do not contactcertain areas of the bone. For instance, in mandibular reconstruction,the fasteners should not contact nerves, teeth, and/or dental implantsto avoid damaging the nerves, the teeth, the dental implant or any otherhardware. It is also important that the fasteners do not interfere witheach other when inserted through the implant holes of the orthopedicimplant. Therefore, it is desirable to adjust the angulation of theimplant holes such that the fasteners do not interfere with each otherand do not contact specific tissue portions such as the nerves andteeth. The location and orientation of the nerves and teeth of eachpatient may vary. Accordingly, it is desirable to produce orthopedicimplants that are specifically designed for a particular patient inorder to adjust the angulation of the implant holes.

SUMMARY

The present disclosure relates to methods of making a patient specificorthopedic implant using, among other things, a computing device runninga computer-aided software. In an embodiment, the method includes one ormore of the following steps: (a) obtaining a virtual three-dimensionalmodel of a tissue body; (b) designing a virtual three-dimensional modelof an orthopedic implant that includes an implant body such that thevirtual three-dimensional model of the orthopedic implant is contouredto fit over a particular portion of the virtual three-dimensional modelof the tissue body; and (c) designing at least one hole that extendsthrough the implant body such that at least one hole is positioned orangled with respect to the implant body so that a virtualthree-dimensional model of a fastener does not extend into apredetermined section of the virtual three-dimensional model of thetissue body when the virtual three-dimensional model of the fastener isat least partially disposed in at least one hole.

In another embodiment, the method includes one or more of the followingsteps: (a) designing a virtual three-dimensional model of an orthopedicimplant that is contoured to fit over a predetermined portion of avirtual three-dimensional model of a tissue body, the virtualthree-dimensional model of the orthopedic implant including an implantbody; and (b) creating at least one virtual hole that extends throughthe implant body of the virtual three-dimensional model of theorthopedic implant such that at least one virtual hole is positioned orangled relative to the implant body so that a virtual three-dimensionalmodel of a fastener extends into a predetermined section of a virtualthree-dimensional model of the tissue body when the virtualthree-dimensional model of the fastener is at least partially disposedin at least one hole.

BRIEF DESCRIPTION OF THE DRAWINGS

The foregoing summary, as well as the following detailed description ofthe preferred embodiments of the application, will be better understoodwhen read in conjunction with the appended drawings. For the purposes ofillustrating the surgical instruments and methods of the presentapplication, there is shown in the drawings preferred embodiments. Itshould be understood, however, that the application is not limited tothe specific embodiments and methods disclosed, and reference is made tothe claims for that purpose. In the drawings:

FIG. 1A is a perspective view of a mandible and a patient specificorthopedic implant that is coupled to the mandible, the orthopedicimplant defining a plurality of holes, each of the holes configured andsized to receive a fastener;

FIG. 1B is a top transparent view of a portion of the mandible and theorthopedic implant shown in FIG. 1A, showing fasteners inserted throughat least some of the holes and into the mandible;

FIG. 1C is a bottom transparent view of the portion of the mandible andthe orthopedic implant shown in FIG. 1B;

FIG. 1D is an enlarged cross-sectional view of a portion orthopedicimplant shown in FIG. 1C, taken around section 1D of FIG. 1C;

FIG. 2A is a perspective view of the patient specific orthopedic implantshown in FIG. 1A;

FIG. 2B is a side view of the patient specific orthopedic implant shownin FIG. 2A;

FIG. 2C is a front view of the patient specific orthopedic implant shownin FIG. 2A;

FIG. 2D is an enlarged cross-sectional view of the patient specificorthopedic implant shown in FIG. 2A, taken along section line 2C-2C ofFIG. 2C;

FIG. 3A is a perspective view of a patient specific orthopedic implantin accordance with another embodiment of the present disclosure;

FIG. 3B is a perspective view of a patient specific orthopedic implantin accordance with yet another embodiment of the present disclosure; and

FIG. 4 shows a method of making the patient specific orthopedic implantsshown in FIGS. 2A-C and 3A-B.

DETAILED DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS

Certain terminology is used in the following description for convenienceonly and is not limiting. The words “right”, “left”, “lower” and “upper”designate directions in the drawings to which reference is made. Thewords “proximally” and “distally” refer to directions toward and awayfrom, respectively, the surgeon using the surgical device. The words,“anterior”, “posterior”, “superior”, “inferior” and related words and/orphrases designate preferred positions and orientations in the human bodyto which reference is made and are not meant to be limiting. Theterminology includes the above-listed words, derivatives thereof, andwords of similar import.

With reference to FIGS. 1A-C, a surgical system may include a patientspecific orthopedic implant 100 that is configured to be coupled to atissue body 10 of a patient. The surgical system may further include oneor more fasteners 108 that are configured to couple the patient specificorthopedic implant 100 to the tissue body 10. One or more fasteners 108can be configured as bone screws 110. Regardless of its configuration,each fastener 108 is configured and sized to be inserted in one of theholes 106 and into the tissue body 10 so as to fix the patient specificorthopedic implant 100 to the tissue body 10. The patent specificorthopedic implant 100 can be contoured to fit over a particular portionof the tissue body 10 of a specific patient. As used herein, the tissuebody 10 may include a patient's bone such as a mandible 16. Although thedrawings show the mandible 16, the tissue body 10 can be other parts ofthe patient's anatomy such the maxilla.

The patient specific orthopedic implant 100 can be used to fix a firsttissue segment 12 of the tissue body 10 to a second tissue segment ofthe tissue body 10. The first tissue segment 12 may be separated fromthe second tissue segment by a defect or diseased tissue portion. Thedefect may be, for example, a fracture. Thus, the first tissue segment12 can be separated from the second tissue segment 14 by a fracture. Thefixation of the first tissue segment 12 and the second tissue segment 14can promote healing of the tissue body 10. Hence, the patient specificorthopedic implant 100 can support and hold the first tissue segment 12relative to the second tissue segment 13 while osteogenesis occurs.Alternatively, the patient specific orthopedic implant 100 can be usedto fix a bone graft to the first tissue segment 12 and the second tissuesegment 14. In such case, a diseased portion of the tissue body 10 maybe removed from the patient and replaced with the bone graft. Theorthopedic implant 100 can then be used to fix the bone graft to thefirst tissue segment 12 and the second tissue segment 14. In particular,the bone graft may separate the first tissue segment 12 from the secondtissue segment 14. Thus, the patient specific orthopedic implant 100 cansupport and hold the bone graft relative to the first tissue segment 12and the second tissue segment 14.

The patient specific orthopedic implant 100 and various of itscomponents are described herein in with reference to orthogonaldirection components. That is, various parts of the orthopedic implant100 can extend along a longitudinal direction L, a lateral direction A,and a transverse direction T. The transverse direction T may besubstantially perpendicular to the lateral direction A and thelongitudinal direction L. Unless otherwise specified herein, the terms“lateral,” “longitudinal,” and “transverse” are used to describe theorthogonal directional components of the various parts of the patientspecific orthopedic implant 100. When the patient specific orthopedicimplant 100 is coupled to the tissue body 10, the transverse direction Textends along the caudal-cranial direction of the patient, the lateraldirection A extends along the medial-lateral direction of the patient,and the longitudinal direction L extends along the anterior-posteriordirection of the patient.

With reference to FIGS. 2A-C, the patient specific orthopedic implant100 can be configured as a bone plate 102 and includes an implant body104 that can be partly or entirely made from any suitable biocompatiblematerial. Suitable biocompatible materials include, but are not limitedto, cobalt chromium molybdenum (CoCrMo), titanium, and titanium alloys,stainless steel, ceramics, or polymers such as polyetheretherketone(PEEK), polyetherketoneketone (PEKK), and bioresorbable materials. Acoating may be added or applied to the implant body 104 to improvephysical or chemical properties or to provide medications. Examples ofcoatings include plasma-sprayed titanium coating or Hydroxyapatite.

The implant body 104 defines an outer implant surface 112 and an opposedinner implant surface 114. The inner implant surface 114 can be spacedfrom the outer implant surface 112 along an axial direction 116. Sincethe implant body 104 may not have a completely planar configuration, theaxial direction 116 may be different along different parts of theimplant body 104. The thickness of the implant body 104 may be definedfrom the outer implant surface 112 to the inner implant surface 114along the axial direction 116. Accordingly, the implant body 104 maydefine one or more thickness axes 118 that extend between the innerimplant surface 114 and the outer implant surface 112. The thicknessaxis 118 may be substantially perpendicular to the inner implant surface114 and the outer implant surface 112. The inner implant surface 114 canbe contoured to match the contour of a particular outer surface of thetissue body 10 so that the patient specific orthopedic implant 100 canonly fit over the that particular outer surface of the tissue body 10.

The patient specific orthopedic implant 100 defines one or more holes106 that extend through the implant body 104 between the inner implantsurface 114 and the outer implant surface 112 (FIG. 2A). Each of theholes 106 can be configured and sized to receive one of the fasteners108 (FIG. 1B). In operation, one fastener 108 can be inserted throughthe hole 106 and into the tissue body 10 to couple the patient specificorthopedic implant 100 to the tissue body 10. The holes 106 may beelongate a hole axis 120 that extends between inner implant surface 114and the outer implant surface 112. The hole axis 120 can be orientedrelative to the thickness axis 118 at an angle θ. In some embodiments,the angle θ may range between about zero (0) to about fifteen (15)degrees. However, the angle θ may be more fifteen (15) degrees. Theholes 106 may have different hole axes 120 having different angulations.For instance, some holes 106 may define hole axes 120 that are orientedat an oblique angle relative to the thickness axes, whereas other holes106 may define hole axes 120 that are substantially parallel to thethickness axis 118. The angulation of the holes 106 relative to thethickness axes 118 may depend on a number of factors. For instance, thesurgeon may desire to orient a specific hole 106 at a particular anglerelative to the thickness axis 118 such that a fastener 108 insertedthrough that hole 106 does not contact nerves, teeth, or any otherdesired tissue portion of the tissue body 10. Moreover, the surgeon maydesire to orient two or more adjacent holes 106 at specific anglesrelative to the thickness axis 118 such that, when fasteners 108 areinserted into these holes 108, the fasteners 108 do not interfere withone another (see FIG. 1D).

The implant body 104 may have internal implant surfaces 122corresponding to each hole 106. Each internal implant surface 122defines one of the holes 106. Some or all of the holes 106 can bethreaded. Therefore, some or all of the holes 106 may include internalimplant threads 124 that are configured to mate with external threads ofthe fastener 108 so that the fastener 108 can be coupled to the implantbody 104. Some or all of the holes 106 may not have internal threads.

The patient specific orthopedic implant 100 may be substantially shapedto match the shape of an outer contour of the tissue body 10. In thedepicted embodiment, the patient specific orthopedic implant 100 can bedesigned to be coupled to one side of the mandible 16. To this end, theimplant body 104 may include a first implant portion 126 and a secondimplant portion 128 that is angularly offset from the first implantportion 126 (FIG. 2A). The first implant portion 126 can be configuredto fit over an anterior surface of the mandible 16. Moreover, the firstimplant portion 126 can be connected to the second implant portion 128at an angular offset. In the depicted embodiment, the first implantportion 126 can be offset relative to the second implant portion 128 atan oblique angle. The second implant portion 128 can be configured tofit over a lateral surface of the mandible 16. The implant body 104 mayfurther include a third implant portion 130 that is angularly offsetfrom the first implant portion 126 and the second implant portion 128.The third implant portion 130 can be connected to the second implantportion 128 at an angular offset. In the depicted embodiment, the thirdimplant portion 130 can be angularly offset relative to the secondimplant portion 128 at an oblique angle. Moreover, the third implantportion 130 can be configured to fit over at least a portion of theramus of the mandible 16.

FIG. 3A shows another embodiment of a patient specific orthopedicimplant 200 that is similar to the patient specific orthopedic implant100 described above. The patient specific implant 200 can be configuredas a bone plate 202 and includes an implant body 204 that is made from asuitable biocompatible material. Suitable biocompatible materialsinclude, but are not limited to, cobalt chromium molybdenum (CoCrMo),titanium, and titanium alloys, stainless steel, ceramics, or polymerssuch as polyetheretherketone (PEEK), polyetherketoneketone (PEKK), andbioresorbable materials. The patient specific implant 200 may furtherdefine a plurality of holes 206 that extend through the implant body204. The holes 206 can be substantially similar to the holes 106 of thepatient specific implant 100 described above. Thus, the holes 206 areconfigured to receive fasteners 108. The implant body 204 can bedesigned to fit over most of the mandible 12. To this end, the implantbody 204 may include a first implant portion 226 and a second implantportion 228 that is angularly offset from the first implant portion 226.The first implant portion 226 can be configured to fit over at least aportion of the ramus of the mandible 16. Moreover, the first implantportion 226 can be connected to the second implant portion 228 at anoblique angle. The second implant portion 228 can be configured to fitover a lateral surface of the mandible 16. The implant body 204 canfurther include a third implant portion 230 that is connected to thesecond implant portion 228. The third implant portion 230 can beconfigured to fit over an anterior surface of the mandible 16. Further,the third implant portion 230 can be angularly offset from the secondimplant portion 228. The implant body 204 includes a fourth implantportion 232 that is connected to the third implant portion 230. Thefourth implant portion 232 can be configured to fit over a lateralsurface of the mandible 16. Moreover, the fourth implant portion 232 canbe angularly offset from the third implant portion 230. The implant body204 includes a fifth implant portion 234 that is connected to the fourthimplant portion 232. The fifth implant portion 234 can be configured tofit over at least a portion of the ramus of the mandible 16. Further,the fifth implant portion 234 can be angularly offset from the fourthimplant portion 232. In the orthopedic arts, the patient specificorthopedic implant 200 is referred to as the double-angled implant.

FIG. 3B illustrates another embodiment of a patient specific implant300. The patient specific implant 300 can be configured to fit over ananterior portion and parts of the two lateral portions of the mandible16. In the depicted embodiment, the patient specific implant 300 can beconfigured as a bone plate 302 and includes an implant body 304. Thepatient specific implant 300 defines holes 306 that extend through theimplant body 304. The holes 306 can be configured to receive fasteners108. The holes 306 can be substantially similar to the holes 106described above. The implant body 304 includes a first implant portion326 and a second implant portion 328 that is connected to the firstimplant portion 326. The first implant portion 326 is configured to fitover a lateral portion of the mandible 16 and is angular offset relativeto the first implant portion 326. The second implant portion 328 can fitover an anterior surface of the mandible 16. The implant body 304 canfurther include a third implant portion 330 that is connected to thesecond implant portion 328. The second implant portion 328 can beangularly offset relative to the second implant portion 328 and can beconfigured to fit over a lateral portion of the mandible 16.

FIG. 4 illustrates a method of making any of the patient specificorthopedic implants described above. In the interest of brevity, thismethod is described in relation to the patient specific orthopedicimplant 100. However, the method can be used to make any of the patientspecific orthopedic implants described above. This method may includesome or all of the steps described below. The patient specificorthopedic implant 100 can be manufactured pre-operatively. Beforecommencing the appropriate surgery, a virtual three-dimensional image ofthe tissue body 10 using any suitable technology is obtained. Thevirtual three-dimensional image of the tissue body 10 can be obtained byscanning the tissue body 10 using a scanning machine 400 that issuitable to scan anatomical tissue. For example, the virtualthree-dimensional image of the mandible 16 can be obtained using thescanning machine 400. The scanning machine 400 can be a computedtomography (CT) scan machine, a laser scanning machine, an opticalscanning machine, a magnetic resonance imaging (MRI) machine, acoordinate measuring machine or any other machine or device capable ofscanning the tissue body 10. Specifically, the scanning machine 400 canbe used to scan the tissue body 10. Regardless of the scanningmethodology employed, a virtual three-dimensional image of the tissuebody 10 is obtained. This image includes images of the tunnels thatreceive the nerves. Accordingly, the location of the nerves in thetissue body 10 can be identified.

Once the virtual three-dimensional image of the tissue body 10 isobtained, the image data obtained by the scanning machine 400 can thenbe downloaded or transferred to a computing device 402 to create avirtual three-dimensional model of the tissue body 10. The computingdevice 402 can be local (i.e., in the same general area as the scanningmachine 400) or remote where the image should be transmitted via anetwork. The computing device 402 includes a processor that is capableof manipulating image data. In addition to the processor, the computingdevice 402 may include a non-transitory computer-readable storage mediumthat is capable of storing image data. Alternatively, the computingdevice 402 may not include a non-transitory computer-readable storagemedium; rather, the computing device 402 may be coupled to anon-transitory computer-readable storage medium. In event, the computingdevice 402 can run a computer-aided design software.

A virtual three-dimensional model of an orthopedic implant, such as theorthopedic implant 100, can be obtained. The virtual three-dimensionalmodel of the orthopedic implant 100 can be composed of data that can bemanipulated by a processor and that can be read by a non-transitorycomputer-readable medium. This data can be in different formats. Forexample, the virtual three-dimensional model of the orthopedic implant100 can include data in a Standard Tessellation Language (STL) format.Irrespective of the data format, the virtual three-dimensional model ofthe orthopedic implant 100 includes data that maps the shape, contour,and size of the orthopedic implant 100. The virtual three-dimensionalmodel of the orthopedic implant 100 can be created virtually in acomputer. In the computing device 402 or another computing device, thevirtual three-dimensional model of the orthopedic implant 100 isdesigned so that is contoured and shaped to fit over a particularportion of the virtual three-dimensional model of the tissue body 10.For example, the virtual three-dimensional model of the orthopedicimplant 100 can be shaped and contoured to fit over an anterior surfaceand a lateral surface of the mandible 16. The virtual three-dimensionalmodels of the orthopedic implant 100 and the tissue body 10 can bemanipulated using a suitable software such as the software sold underthe trademark PROPLAN CMF® by Synthes.

The virtual three-dimensional model of the orthopedic implant 100 isthen processed so as to create one or more holes 106. The user such as asurgeon can determine the angulation and position of the holes 106 inaccordance with a predetermined surgical plan. Specifically, the virtualthree-dimensional model of the orthopedic implant 100 can be manipulatedso that the holes 106 are positioned relative to the implant body 104such that the fasteners 108 do not extend into a predetermined sectionof the tissue body 10 when the fasteners are at least partially disposedin the holes 106. For example, the virtual three-dimensional model ofthe orthopedic implant 100 can be manipulated so that the holes 106 arepositioned along the implant body 104 so that the fasteners 108 wouldnot contact nerves or teeth of the tissue body 10. Similarly, thevirtual three-dimensional model of the orthopedic implant 100 can bemanipulated so that the holes 106 are angled relative to the implantbody 104 so that the fasteners 108 would not contact nerves, teeth,and/or dental implants of the tissue body 10. The holes 106 can bepositioned or aligned so that the fasteners 108 would not contact anytype of hardware such as a dental implant. The user can also manipulatethe virtual three-dimensional model of the orthopedic implant 100 toadjust the position and/or angulation of the holes 106 such that thefasteners 108 do not contact one another when the fasteners 108 asillustrated in FIG. 1D. In determining the proper position and/orangulation of the holes 106 with respect to the implant body 104, theuser may select the fasteners 108 with the appropriate length so thatthe fasteners 108 do not interfere with one another when the fasteners108 are inserted in the holes 106. It is envisioned that the virtualthree dimensional models of the fasteners 108 can be obtained. Thevirtual three-dimensional models of the fasteners 108 can be insertedthrough the holes 108 of the virtual three-dimensional model of theorthopedic implant 100 to determine whether the fasteners 108 extendinto nerves, teeth, or interfere with one another. If the virtualthree-dimensional models of the fasteners 108 interfere with nerves,teeth, or each other, the position or angulation of the holes 108 of thevirtual three-dimensional model of the orthopedic implant 100 can bemanipulated. It is envisioned that the surgeon may manipulate thevirtual three-dimensional model of the orthopedic implant 100 before thesurgery to reduce the amount of time that is spent in the operating roomadjusting the orthopedic implant 100 so that it fits the particularpatient. Since the operating room time is reduced, the duration of theanesthesia can be reduced as well.

Once the virtual three-dimensional model of the orthopedic implant 100has been completed, the orthopedic implant 100 can be created using anysuitable technology. The completed virtual three-dimensional model ofthe orthopedic implant 100 can be downloaded or transferred from thecomputing device 402 to a manufacturing machine 404 such as a CAD/CAMmanufacturing machine. The completed virtual three-dimensional model ofthe orthopedic implant 100 can be transferred or downloaded directlyfrom the computing device 402 to the manufacturing machine 404 or fromthe computing device 402 to another computer and then to themanufacturing machine 404. The manufacturing machine 404 can be acomputer numerical control (CNC) machine. A suitable software can beused to generate CNC code from the data that represents the virtualthree-dimensional model of the orthopedic implant 100. For example, asoftware sold under the trademark SYNOPSIS™ by CADS GmbH can be used togenerate the CNC code from the virtual three-dimensional model of theorthopedic implant 100. The software can generate CNC code in anysuitable programming language. For instance, the SYNOPSIS or any othersuitable software can generate CNC code in G-code or STEP-NC programminglanguages. The CNC code can then be downloaded or transferred to the CNCmachine so that the CNC machine can manufacture the patient specificorthopedic implant 100.

It is envisioned that the methods described above can used not only tomanufacture the orthopedic implants described herein but also otherorthopedic implants or guiding implant. For instance, the methoddescribed herein can be used to manufacture the bone fixation implantand the osteotomy guiding implant that are described in U.S. PatentApplication Publication No. 2012/0029574, filed on Apr. 1, 2011, theentire disclosure of which is incorporated herein by reference.Furthermore, the methods described herein can used to manufacture andcustomize the bone fixation device, bone plate, and aiming guide thatare described in U.S. patent application Ser. No. 13/426,079 filed onMar. 21, 2012, the entire disclosure of which is incorporated byreference.

It should be noted that the illustrations and discussions of theembodiments shown in the figures are for exemplary purposes only, andshould not be construed limiting the disclosure. One skilled in the artwill appreciate that the present disclosure contemplates variousembodiments. For example, although the present disclosure refers tovirtual three-dimensional models, it is envisioned that any of thevirtual models described in the present disclosure can betwo-dimensional. It should be further appreciated that the features andstructures described and illustrated in accordance one embodiment canapply to all embodiments as described herein, unless otherwiseindicated. Additionally, it should be understood that the conceptsdescribed above with the above-described embodiments may be employedalone or in combination with any of the other embodiments describedabove.

What is claimed is:
 1. A method, comprising: obtaining a virtualthree-dimensional model of a tissue body; designing, via a softwareprogram executed by a computing device, a virtual three-dimensionalmodel of an orthopedic implant that includes an implant body such thatthe virtual three-dimensional model of the orthopedic implant iscontoured to fit over a particular portion of the virtualthree-dimensional model of the tissue body, the implant body beingelongate along a longitudinal axis, the implant body including at leastone hole that extends along a hole axis that is angled with respect tothe longitudinal axis of the implant body; manipulating, via thesoftware program, the virtual three-dimensional model of the orthopedicimplant to overlay the particular portion of the virtualthree-dimensional model of the tissue body so as to define a manipulatedvirtual three-dimensional model of the orthopedic implant; inserting,via the software program, a virtual three-dimensional model of afastener at least partially into the at least one hole of the implantbody so that the virtual three-dimensional model of the fastener doesnot extend into a predetermined section of the obtained virtualthree-dimensional model of the tissue body, wherein the predeterminedsection of the obtained virtual three-dimensional model of the tissuebody includes a nerve, a tooth, or hardware; and transferring themanipulated virtual three-dimensional model of the orthopedic implant toa manufacturing machine, wherein the manufacturing machine is configuredto construct a patient specific orthopedic implant that corresponds tothe manipulated virtual three-dimensional model of the orthopedicimplant.
 2. The method according to claim 1, wherein the predeterminedsection is an intersection with another fastener that extends throughthe implant body.
 3. The method according to claim 1, wherein the tissuebody is a mandible and the obtaining step includes obtaining a virtualthree-dimensional model of the mandible.
 4. The method according toclaim 1, wherein the tissue body is a maxilla and the obtaining stepincludes obtaining a virtual three-dimensional model of the maxilla. 5.The method according to claim 1, wherein the obtaining step includesscanning the tissue body using a scanning machine selected from thegroup consisting of a computed tomography (CT) scan machine, a laserscanning machine, an optical scanning machine, a magnetic resonanceimaging (MRI) machine, and a coordinate measuring machine.
 6. The methodaccording to claim 1, wherein the at least one hole is a first hole, thevirtual three-dimensional model of the fastener is a virtualthree-dimensional model of a first fastener, and the method comprisesthe step of designing a second hole that extends through the implantbody such that second hole is positioned or angled with respect to theimplant body so that a virtual three-dimensional model of a secondfastener does not contact the virtual three-dimensional model of thefirst fastener when the virtual three-dimensional models of the firstand second fasteners are at least partially disposed in the first andsecond holes of the manipulated virtual three-dimensional model of theorthopedic implant, respectively.
 7. The method according to claim 1,further comprising constructing the patient specific orthopedic implantto correspond to the manipulated virtual three-dimensional model of theorthopedic implant using the manufacturing machine.
 8. The method ofclaim 7, further comprising generating a CNC code using data thatrepresents the manipulated virtual three-dimensional model of theorthopedic implant and the at least one hole.
 9. The method of claim 8,wherein the constructing step includes transferring the CNC code to aCNC machine.
 10. The method of claim 9, wherein the constructing stepincludes constructing the patient specific orthopedic implant using theCNC machine.
 11. The method according to claim 1, wherein themanipulating step includes coupling the virtual three-dimensional modelof the orthopedic implant to the virtual three-dimensional model of thetissue body.
 12. The method of claim 1, further comprising programmingthe manufacturing machine to construct the patient specific orthopedicimplant that corresponds to the manipulated virtual three-dimensionalmodel of the orthopedic implant.
 13. The method of claim 1, whereinafter the inserting step, redesigning the manipulated virtualthree-dimensional model of the orthopedic implant if the virtualthree-dimensional model of the fastener extends into the predeterminedsection of the obtained virtual three-dimensional model of the tissuebody.
 14. The method of claim 13, wherein the redesigning step includesadjusting a position or angulation of the at least one virtual hole ofthe manipulated virtual three-dimensional model of the orthopedicimplant.
 15. A method, comprising: designing, via a software programexecuted by a computing device, a virtual three-dimensional model of anorthopedic implant that is contoured to fit over a predetermined portionof a virtual three-dimensional model of a tissue body, the virtualthree-dimensional model of the orthopedic implant including an implantbody that is elongate along a longitudinal axis, and at least onevirtual hole that extends through the implant body of the virtualthree-dimensional model of the orthopedic implant along a hole axis thatis angled with respect to the longitudinal axis of the implant body;manipulating, via the software program, the virtual three-dimensionalmodel of the orthopedic implant to overlay the predetermined portion ofthe virtual three-dimensional model of the tissue body so as to define amanipulated virtual three-dimensional model of the orthopedic implant;inserting, via the software program, a virtual three-dimensional modelof a fastener at least partially into the at least one virtual hole ofthe implant body so that the virtual three-dimensional model of thefastener does not extend into a predetermined section of the obtainedvirtual three-dimensional model of the tissue body, wherein thepredetermined section of the obtained virtual three-dimensional model ofthe tissue body includes a nerve, a tooth, or hardware; and transferringthe manipulated virtual three-dimensional model of the orthopedicimplant to a manufacturing machine, wherein the manufacturing machine isconfigured to construct a patient specific orthopedic implant thatcorresponds to the manipulated virtual three-dimensional model of theorthopedic implant.
 16. The method of claim 15, further comprisingobtaining the virtual three-dimensional model of the tissue body. 17.The method of claim 16, wherein the obtaining step includes scanning thetissue body using a scanning machine.
 18. The method of claim 16,wherein, in the obtaining step, the scanning machine is selected from agroup consisting of a computed tomography (CT) scan machine, a laserscanning machine, an optical scanning machine, a magnetic resonanceimaging (MRI) machine, and a coordinate measuring machine.
 19. Themethod of claim 16, wherein, in the obtaining step, the tissue body is amandible, and the obtaining step further includes scanning the mandibleusing the scanning machine.
 20. The method of claim 15, furthercomprising constructing a physical orthopedic implant to correspond tothe manipulated virtual three-dimensional model of the orthopedicimplant using the manufacturing machine.
 21. The method of claim 20,further comprising generating a CNC code using data that represents thevirtual three-dimensional model of the orthopedic implant and the atleast one virtual hole.
 22. The method of claim 21, wherein theconstructing step includes transferring the CNC code to a CNC machine.23. The method of claim 22, wherein the constructing step includeconstructing the physical orthopedic implant using the CNC machine. 24.The method of claim 15, wherein the at least one virtual hole is a firstvirtual hole, the virtual three-dimensional model of the fastener is avirtual three-dimensional model of a first fastener, and the methodcomprises the step of designing a second virtual hole such that thesecond virtual hole is positioned and angled with respect to the implantbody so that a virtual three-dimensional model of a second fastener doesnot interfere with the virtual three-dimensional model of the firstfastener when the virtual three-dimensional models of the first andsecond fasteners are at least partially disposed in the first and secondvirtual holes of the manipulated virtual three-dimensional model of theorthopedic implant, respectively.
 25. The method of claim 15, whereinthe designing step includes obtaining location data that includesinformation about an angle or position of the at least one virtual holerelative to the implant body.
 26. The method of claim 15, furthercomprising programming the manufacturing machine to construct thepatient specific orthopedic implant that corresponds to the manipulatedvirtual three-dimensional model of the orthopedic implant.
 27. Themethod of claim 15, wherein after the inserting step, redesigning themanipulated virtual three-dimensional model of the orthopedic implant ifthe virtual three-dimensional model of the fastener extends into thepredetermined section of the obtained virtual three-dimensional model ofthe tissue body.
 28. The method of claim 27, wherein the redesigningstep includes adjusting a position or angulation of the at least onevirtual hole of the manipulated virtual three-dimensional model of theorthopedic implant.